Trial Outcomes & Findings for Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists (NCT NCT00859131)

NCT ID: NCT00859131

Last Updated: 2016-04-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: One year
• Results posted on: 2016-04-26

Participant Flow

Participant milestones

Measure	Thymoglobulin Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Overall Study STARTED	102	98
Overall Study COMPLETED	102	98
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

Baseline characteristics by cohort

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7	Total n=200 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 13 • n=5 Participants	49 years STANDARD_DEVIATION 14 • n=7 Participants	50.2 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.	6 participants	10 participants

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.	3 Patients	8 Patients

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Graft Survival at One Year Post-transplant	101 participants	95 participants

SECONDARY outcome

Timeframe: one year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis	52 participants	58 participants

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.	3 participants	0 participants

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3	21 participants	4 participants

SECONDARY outcome

Timeframe: One year

Outcome measures

Measure	Thymoglobulin n=102 Participants Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 Participants subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3	43 participants	13 participants

Adverse Events

Thymoglobulin

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Zenapax

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Thymoglobulin n=102 participants at risk Subjects receiving Thymoglobulin as induction agent in renal transplantation Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4	Zenapax n=98 participants at risk subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Blood and lymphatic system disorders BK Viremia	12.7% 13/102	19.4% 19/98
Immune system disorders CMV	28.4% 29/102	18.4% 18/98
Infections and infestations Bacterial Infection	9.8% 10/102	21.4% 21/98

Additional Information

Kenneth Chavin, MD, PhD

Medical University of South Carolina

Phone: 843-792-3368

Email: chavinkd@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place